Alembic Pharma Gets USFDA Approval for Divalproex Sodium Capsules, 125 mg Kumar Jeetendra | December 20, 2024 Alembic Pharmaceuticals Limited (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Divalproex Sodium Delayed-Release Capsules USP, 125 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Depakote Sprinkle Capsules, 125 mg, of AbbVie Inc. Alembic …
Alembic Pharma Gets USFDA Nod for Ticagrelor 60 mg Tablets Kumar Jeetendra | November 1, 2025 Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ticagrelor Tablets, 60 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Brilinta Tablets, 60 mg, of AstraZeneca Pharmaceuticals LP (AstraZeneca). Ticagrelor tablets are …
Alembic Gets USFDA Nod for Sumatriptan Injection Autoinjector Kumar Jeetendra | November 10, 2025 Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Sumatriptan Injection USP, 4 mg/0.5 mL and 6 mg/0.5 mL, Single-Dose Autoinjector System. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Imitrex STATdose System, …
Alembic Pharma Receives USFDA Approval for Haloperidol Tablets Kumar Jeetendra | June 5, 2026 Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Haloperidol Tablets, USP, 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Haldol …
Alembic Gets USFDA Final Approval for Tretinoin Cream 0.05% Kumar Jeetendra | June 15, 2026 Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tretinoin Cream USP, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.05%, of Bausch Health US, LLC. Tretinoin cream is …
